Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
LIAISON NES Influenza FLU AB Respiratory Syncytial Virus RSV Coronavirus Disease 2019 COVID-19 in Symptomatic Patients in Australia
Sponsor:
DiaSorin Molecular LLC
Organization:
DiaSorin Molecular LLC
Study Overview
Official Title:
A Multi-Site Clinical Evaluation of the LIAISON NES FLU AB RSV COVID-19 and LIAISON PLEX Respiratory RSP Flex Assays in Symptomatic Patients in Australia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To establish the relative accuracy of the LIAISON NES Flu AB RSV COVID-19 assay for viral nucleic acid targets from professionally collected or patient self-collected dry nasal NS swabs and to establish the relative accuracy of the LIAISON PLEX RSP Flex assay from NS and nasopharyngeal swabs NPS in applicable transport media from human patients exhibiting clinical signs and symptoms of a respiratory tract infection
Detailed Description:
This study is a clinical evaluation of two investigational devices on the same patient specimens
The LIAISON NES FLU AB RSV COVID-19 assay used for the detection and identification of influenza A influenza B RSV and SARS-CoV-2 on the LIAISON NES system developed by DiaSorin Molecular
The LIAISON PLEX RSP Flex assay used for the detection and identification of 19 common respiratory pathogens including 14 viral and 5 bacterial targets on the LIAISON PLEX system developed by Luminex Corporation a subsidiary of DiaSorin
This study will utilize untrained operators to perform investigational device testing on the LIAISON NES platform and as such instrument or assay-specific training will not be provided beforehand Sites will receive the necessary protocols and instructions for use required to implement the study protocol Testing on the LIAISON PLEX platform will be performed by trained operators Study staff will receive training on the device prior to the start of testing The diagnostic accuracy of the LIAISON NES FLU AB RSV COVID-19 assay will be evaluated using dry NS specimens prospectively collected from patients who meet the study inclusion criteria The diagnostic accuracy of the LIAISON PLEX RSP Flex assay will be evaluated using NS and NPS specimens prospectively collected from patients who meet the study inclusion criteria and stored in the applicable transport media Performance of the LIAISON NES FLU AB RSV COVID-19 and LIAISON PLEX RSP Flex assays will be compared to one or more US FDA-cleared molecular assays or as required by the local regulatory body
Approximately 600-1000 prospective specimens will be tested using the LIAISON NES FLU AB RSV COVID-19 and LIAISON PLEX RSP Flex assays with a goal to obtain approximately 50 comparator method confirmed positives per target for influenza A and SARS CoV-2 and 30 comparator method confirmed positives per target for influenza B and RSV The study is estimated to be conducted for approximately 3 months and should cover the length of the flu season as appropriate
The LIAISON NES FLU AB RSV COVID-19 assay used for the detection and identification of influenza A influenza B RSV and SARS-CoV-2 on the LIAISON NES system developed by DiaSorin Molecular
The LIAISON PLEX RSP Flex assay used for the detection and identification of 19 common respiratory pathogens including 14 viral and 5 bacterial targets on the LIAISON PLEX system developed by Luminex Corporation a subsidiary of DiaSorin
This study will utilize untrained operators to perform investigational device testing on the LIAISON NES platform and as such instrument or assay-specific training will not be provided beforehand Sites will receive the necessary protocols and instructions for use required to implement the study protocol Testing on the LIAISON PLEX platform will be performed by trained operators Study staff will receive training on the device prior to the start of testing The diagnostic accuracy of the LIAISON NES FLU AB RSV COVID-19 assay will be evaluated using dry NS specimens prospectively collected from patients who meet the study inclusion criteria The diagnostic accuracy of the LIAISON PLEX RSP Flex assay will be evaluated using NS and NPS specimens prospectively collected from patients who meet the study inclusion criteria and stored in the applicable transport media Performance of the LIAISON NES FLU AB RSV COVID-19 and LIAISON PLEX RSP Flex assays will be compared to one or more US FDA-cleared molecular assays or as required by the local regulatory body
Approximately 600-1000 prospective specimens will be tested using the LIAISON NES FLU AB RSV COVID-19 and LIAISON PLEX RSP Flex assays with a goal to obtain approximately 50 comparator method confirmed positives per target for influenza A and SARS CoV-2 and 30 comparator method confirmed positives per target for influenza B and RSV The study is estimated to be conducted for approximately 3 months and should cover the length of the flu season as appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None